On September 29 and 30, 2005, we inspected your seafood importing and distributing facility, Viet-Link Co., located in West Bridgewater, Massachusetts . The inspection was conducted to determine your firm's compliance with FDA's seafood Hazard Analysis and Critical Control Points (HACCP) regulations for Fish and Fishery Products, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123) and the Good Manufacturing Practice (GMP) requirements for foods (21 CFR Part 110).

During our inspection, the Investigator observed serious deviations from the special requirements for imported fish and fishery products (21 CFR Part 123.12). Pursuant to 21 CFR Part 123.6(g), failure of a processor to operate in accordance with the requirements of 21 CFR Part 123 renders that processor's fish or fishery products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4). You may find the Act and seafood HACCP regulations through links in FDA's homepage at www.fda.gov.

1. You must have product specifications that are designed to ensure that the fish and fishery products that you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm does not have product specifications for frozen whole red snapper cleaned, frozen whole spotted grouper cleaned, and Spanish mackerel chunks manufactured by [redacted] in Viet Nam.

2. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for frozen whole red snapper cleaned, frozen whole spotted grouper cleaned, and Spanish mackerel chunks manufactured by [redacted] in Viet Nam.

The above-identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all seafood products processed and distributed by your firm are in compliance with the Act and all requirements of the federal regulations.

You should take prompt measures to correct these deviations. Failure to promptly correct the deviations noted may result in regulatory action without further notice. Such action includes seizure and/or injunction. In addition, FDA may detain your imported seafood products without examination.

Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct these violations, including an explanation of each step taken to prevent their reoccurrence. Your response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.

If you have any questions regarding the implementation of the HACCP regulations, you may contact Mr. Ota at 781-596-7762 for answers and/or direction towards guidance and sources of training in achieving compliance.

We look forward to working with you to achieve a successful HACCP program.

Sincerely,/s/

W. Biovin for Michael R. Kravchuk Acting District Director New England District